CHATTANOOGA

Basic Information

• Brand Name: CHATTANOOGA
• Primary DI: 07630039100759
• Version / Model: Intelect F-SW
• Company Name: Storz Medical AG
• Labeler DUNS: 481967776
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 61e77d69-ff50-4571-af7e-0c5b232f2489
• Distribution End Date: 2017-01-16

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBN	Generator, Shock-Wave, For Pain Relief	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47995	Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system	An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. It is typically mobile and includes a control unit that uses both an electrical current and compressed air to create kinetic energy which is transferred to a patient's body upon contact (e.g., with two different hand-held surface applicators) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630039100759	GS1

Premarket Submissions

Submission Number	Supplement Number
P080028	000